Original Title: Application 1053

Authors' results and conclusions: Safety - Good quality data are not available to assess the safety of artificial bowel sphincter (ABS) placement in the treatment of faecal incontinence. Poor quality data on follow-up indicate a number of safety issues that need to be addressed. The high explantation rate (30.5%) and high level of adverse events suggests that this procedure can be harmful to the patient. Infection, device malfunction, ulceration and pain are common adverse events, and in many cases they require surgical revision procedures. The lack of follow-up is a further concern as there is no information on whether an unsuccessful surgical procedure has a detrimental physical and/or psychological impact on the patient. There is also a lack of long-term safety data and uncertainty surrounds the life expectancy of the device once it is implanted. Effectiveness - There are no studies available that assess the effectiveness of an artificial bowel sphincter for treating faecal incontinence in comparison to dynamic graciloplasty. Only available case series evidence was assessed. All studies included in this assessment are flawed in their appraisal of outcomes in that patient results are not analysed on an intention-to-treat basis, which may lead to misleading findings in respect to the effectiveness of the procedure. From the low-level evidence available, it would appear that for the majority of patients the procedure has uncertain benefits. Methodological deficiencies that need to be addressed include the supply of all short- and long-term outcome data on an intention-to-treat basis, specifically quality of life and continence status, of all patients implanted with an ABS, including explanted patients. Implantation of an ABS is a complex procedure and should be limited to patients suffering severe faecal incontinence who have exhausted all other avenues of conservative medical treatment, such as biofeedback, medical therapy and less rigorous surgery. Cost-effectiveness - It is not possible to assess the cost-effectiveness of the procedure due to a lack of high quality evidence on clinical effectiveness.

Authors' recommendations: As insufficient evidence pertaining to the safety and effectiveness of the placement of ABS in the management of faecal incontinence has emerged since this technology was previously considered by the Medical Services Advisory Committee (MSAC), the MSAC recommends that public funding should not be supported for this procedure.

Project Status: Completed

URL for project: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1053-public

Year Published: 2003

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/872BF92EF7BA4FBECA25801000123B24/$File/1053%20-Assessment-Report.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)